U.S. ENVIRONMENTAL PROTECTION AGENCY



## OFFICE OF INSPECTOR GENERAL



# EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal

Report No. 12-P-0508 May 25, 2012

Scan this mobile code to learn more about the EPA OIG.Report Contributors: Carolyn Copper
Steve Hanna Roopa Batni Tapati Bhattacharyya
Brooke Shull

Abbreviations

BMP Best Management Practice EPA U.S. Environmental Protection Agency GAO U.S. Government Accountability Office HWPs Hazardous waste pharmaceuticals NIOSH National Institute for Occupational Safety and Health OIG Office of Inspector General ORCR Office of Resource Conservation and Recovery OSHA Occupational Safety and Health Administration OSWER Office of Solid Waste and Emergency Response RCRA Resource Conservation and Recovery Act
UWR Universal Waste Rule

Cover photo: Examples of pharmaceuticals. (EPA photo)



# Hotline

To report fraud, waste, or abuse, contact us through one of the following methods:

e-mail: OIG_Hotline@epa.gov write: EPA Inspector General Hotline phone: fax: 1-888-546-8740 202-566-2599 1200 Pennsylvania Avenue NW Mailcode 2431T online: http://www.epa.gov/oig/hotline.htm Washington, DC 20460U.S. Environmental Protection Agency 12-P-0508 May 25, 2012 Office of Inspector General 

# At a Glance

Why We Did This Review

We conducted this review to
evaluate the U.S.
Environmental Protection Agency’s (EPA’s) process to identify and appropriately classify pharmaceuticals as
hazardous waste and to ensure their safe disposal.

Background

The discovery of a variety of pharmaceuticals in water has
raised concerns about potentially adverse environmental consequences of
these contaminants. Studies have suggested the detection of pharmaceutical compounds in treated wastewater effluent, streams, lakes, seawater, drinking water, and groundwater, as well as in
sediments and fish tissue. EPA has the authority under the
Resource Conservation and Recovery Act (RCRA) to regulate hazardous waste pharmaceuticals (HWPs) to ensure safe management and disposal practices.

For further information, contact our Office of Congressional and Public Affairs at (202) 566-2391.

The full report is at: www.epa.gov/oig/reports/2012/ 20120525-12-P-0508.pdf 

## EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal

What We Found

Since 1980, EPA has not used its RCRA authority to determine whether pharmaceuticals may qualify as hazardous waste. EPA also has not established a process for the regular identification and review of pharmaceuticals that may qualify for regulation as hazardous waste. Without a regular process, EPA cannot provide assurance that pharmaceuticals that may pose a hazardous risk to human health and the environment have been identified. We identified eight chemicals found in pharmaceuticals that meet EPA’s criteria for regulation as acute hazardous waste, but wastes containing these chemicals are not regulated as such. There are over 100 drugs that federal occupational safety organiza tions have identified as hazardous but may not have been reviewed by EPA to dete rmine whether they may qualify as hazardous waste. EPA staff stated they have started examining these drugs for listing as hazardous waste. Further, the state of Minn esota recently noted that there has been a proliferation of pharmaceutical devel opment since RCRA regulations were established. Our review has identified a risk that there are unknown but potentially dangerous unregulated HWPs that may be unsafely disposed and released into the
environment.

An additional challenge to ensuring the safe disposal of HWPs is that some health care facilities, such as hospitals, may be unaware of federal hazardous waste regulations. The state of Minnesota, for exampl e, has reported that there is a “general lack of awareness by the health care industry of RCRA regulatory requirements.” This may result in mismanagement of hazardous waste pharmaceuticals.

In 2008, EPA proposed an amendment to the Universal Waste Rule to address pharmaceutical wastes. However, no action on the Rule has occurred since the close of the public comments period in 2009. During our review, EPA staff informed us that the Agency has decided to develop another proposal for the regulation of hazardous waste pharmaceuticals at health car e facilities. EPA staff stated that “due to substantial negative public comment s received on the 2008 universal waste proposal, the Agency is developing a revised proposal for regulation of hazardous waste pharmaceuticals at h ealthcare facilities.” EPA anticipates the proposal will be available for public comment in spring 2013.

What We Recommend

We recommend that EPA establish a process to review pharmaceuticals for regulation as hazardous waste and develop an outr each and compliance assistance plan for health care facilities managing HWPs.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

THE INSPECTOR GENERAL

May 25, 2012

MEMORANDUM

SUBJECT: EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal Report No. 12-P-0508

FROM: Arthur A. Elkins, Jr.

TO: Mathy Stanislaus
Assistant Administrator for Solid Waste and Emergency Response

This is our report on the subject evaluation cond ucted by the Office of Inspector General (OIG)
of the U.S. Environmental Protec tion Agency (EPA). This report co ntains findings that describe the problems the OIG has identified and corr ective actions the OIG recommends. This report represents the opinion of the OIG and does not necessarily represent the final EPA position.
Final determinations on matters in this report will be made by EP A managers in accordance with established resolution procedures.

Action Required

In accordance with EPA Manual 2750, you are require d to provide a written response to this report within 90 calendar days. The recommendati ons are listed as unresolved because planned completion dates were not provided. Your response should include a correc tive action plan for agreed-upon actions, including actual or estimate d milestone completion dates. Your response will be posted on the OIG’s public website, along with our comments on your response. Your response should be provided in an Adobe PDF file that complies with the accessibility requirements of Section 508 of the Rehabilita tion Act of 1973, as amended. Please e-mail your response to Carolyn Copper at copper.carolyn@epa.gov . If your response contains data that you do not want to be released to the public, you s hould identify the data for redaction. We have no objections to the further release of this report to the public.

If you or your staff have any questions regardin g this report, please c ontact Carolyn Copper at (202) 566-0829 or copper.carolyn@epa.gov , or Steve Hanna at (415) 947-4527 or hanna.steve@epa.gov

.EPA Inaction in Identifying Hazardous Waste 12-P-0508 Pharmaceuticals May Result in Unsafe Disposal 

# Table of Contents

Chapters

1 Introduction

........................................................................................................ 1

Purpose

....................................................................................................... 1 Background

................................................................................................. 1 Scope and Methodology

.............................................................................. 5 Prior Evaluation Coverage

.......................................................................... 6

2 EPA Has Not Used Its Authority to Assess and Manage Potential Hazards of Pharmaceutical Waste

................................................... 7

EPA Has Not Used Its Hazardous Waste Management Authority

.............. 7 Health Care Facilities May be Unaware of Their RCRA Obligations

........... 9 EPA Is Developing a New Pharmaceutical Rulemaking

.............................. 10 Conclusion

................................................................................................... 11 Recommendations

...................................................................................... 11 Agency Response and OIG Evaluation

....................................................... 11

Status of Recommendations and Potential Monetary Benefits

.............................. 13



## Appendices

A Pharmaceuticals Meeting Acute Hazardous Waste Criteria

........................... 14

B Agency Response to Draft Report and OIG Comment

................................... 15

C Distribution

......................................................................................................... 30

# Chapter 1

Introduction

Purpose The purpose of this review was to eval uate the U.S. Environmental Protection Agency’s (EPA’s) process to identify a nd appropriately classify pharmaceuticals
as hazardous waste and to ensure their sa fe disposal. We addressed the following questions:

1. Do EPA’s hazardous waste codes appr opriately classify pharmaceuticals
as hazardous waste?
2. What process has EPA established to identify and list new pharmaceuticals as hazardous waste?
3. What steps have states taken to identify and regula te additional pharmaceuticals as hazardous waste?
4. How will the Universal Waste Rule (UWR) impact the management of hazardous waste pharmaceuticals (HWPs)? What is the current status of
the rule?



### Background

The discovery of a variety of pharma ceuticals in surface, ground, and drinking waters around the country has raised c oncerns about the po tentially adverse environmental consequences of these contaminants. Although the effects on humans are unknown, the U.S. Government Accountability Office (GAO) reports that some research has demonstrated the potential impact to human health from exposure to pharmaceuticals found in drinking water, such as antibiotics and those
that interfere with human hormone development. In addition, minute concentrations of some pharmaceuticals can have detrimental effects on aquatic species, such as hormonal imbalances l eading to feminization and reproductive problems in fish populations. Studies have suggested the detection of pharmaceutical compounds in treated wastewater effluent, streams, lakes, seawater, and groundwater, as well as in sediments and fish tissue. For example, during 1999 and 2000, the United States Geol ogical Survey conducted a study of 139 streams across the country and de tected pharmaceutical compounds in 80 percent of the streams sampled.

In the 2008 proposed universal waste rule, EPA defines a pharmaceutical as any chemical product, vaccine, or allergenic , not containing a ra dioactive component, that is intended for use in the diagnosi s, cure, mitigation, treatment, or prevention of disease or injury in humans or anim als. This definition also refers to any product with the primary purpose of disp ensing or delivering a pharmaceutical.

12-P-0508 1Pharmaceutical waste 1 includes expired drugs, personal medications, waste materials containing excess dr ugs (syringes, IV bags, t ubing, vials, etc.), and drugs that are intended to be discarded. Generators of hazardous waste pharmaceuticals (HWPs) include: pharmacies, physicians’ and dentists’ offices, outpatient care centers, ambulatory health car e services, residential care facilities, veterinary clinics, and reverse distributors. 2 Health care facilities may dispose of unused pharmaceuticals, especially residues, down the drain (e.g., intravenous (IV) bags emptied into the sink). Accordi ng to EPA, for many years, a standard disposal practice at many health car e facilities was to flush unused pharmaceuticals down the toilet or drain. Although the domestic sewage exclusion generally allows facilities to flush pharmaceuticals down the drain,
EPA believes that facilities should not dispose of thei r pharmaceuticals down the
drain.

EPA Definition of Hazardous Waste

Under the Resource Conservation and Recovery Act (RCRA), EPA has the authority to regulate the generation, st orage, transportati on, treatment, and disposal of hazardous waste. Most stat es have been delegated the primary responsibility for regulating RCRA hazar dous waste. Any facility, such as hospitals and other health f acilities that generate more than 100 kg (220 lbs.) of hazardous waste per month, or greater than 1 kg (2.2 lbs.) of acute hazardous waste per month, are subject to RCRA hazardous waste regulations. RCRA requires that hazardous wastes be transpor ted in approved containers to permitted hazardous waste disposal facilities by a hazardous waste transporter. RCRA prohibits disposal of hazardous waste in municipal waste landfills, municipal incinerators, or medical waste plants. 3

EPA’s RCRA regulations establish two wa ys of identifying hazardous waste:

1. Characteristic hazardous waste – A waste may be considered hazardous if
it exhibits one of the four defined characteristics of hazardous waste:

a. Ignitability – wastes that can readily catch fire and maintain
combustion.
b. Corrosivity – wastes that ar e acidic or alkaline (basic).

c. Reactivity – wastes that read ily explode or undergo violent
reactions or react by releasing toxic gases or fumes.
d. Toxicity – wastes likely to leach dangerous concentrations of toxic chemicals into groundwater.

1 Under RCRA, EPA does not regulate pharmaceuticals until they are discarded as waste.

2 Reverse distributors are private compan ies that provide a service to the hea lth care industry by keeping track of manufacturer unused pharmaceutical re imbursement policies, and thus get health care facilities credit for the pharmaceuticals prior to sending them off-site for disposal.

3 RCRA excludes hazardous waste generated by house holds from the definition of hazardous waste.

12-P-0508 22. Listed hazardous waste – EPA may also explic itly identify hazardous wastes through a listing process. Lists of hazardous waste developed by
EPA are:

a. F-list (wastes from non-specific sour ces) – hazardous wastes from certain common industrial and manufacturing processes.
b. K-list (wastes from specific industries).

c. P- and U- lists of chemicals – hazardous wastes including specific
unused chemicals. Chemicals ar e included on the U-list based on toxicity or other characteristics. Chemicals are included on the P-list if they are acutely toxic. P-list chemicals are regulated when generated in lower quantities than U-list chemicals.

P-listed wastes are identified as acute hazardous waste because the waste has been
found to be fatal to humans or animals above certain thresholds/doses. EPA can regulate a waste as acutely hazardous if it has been shown in studies to have:

 an oral Lethal Dose 50 4 toxicity for rats of less than 50 milligrams per kilogram,

 an inhalation Lethal Concentration 50 toxicity for rats of less than 2 milligrams per liter, or

 a dermal Lethal Dose 50 toxicity fo r rabbits of less than 200 milligrams per kilogram

EPA also can regulate a waste as acutely ha zardous if it is capab le of causing or significantly contributing to an increase in serious irreversible or incapacitating
reversible illness.

Pharmaceuticals can be included on the U-lis t if they exhibit any of the four hazardous characteristics described above, or if they contain a toxic constituent and are capable of posing a “substantia l present or potential hazard to human health or the environment when impr operly treated, stored, transported, or disposed of, or otherwise managed.” Toxic constituents identified by RCRA are chemical compounds or elements which scie ntific studies show to have toxic, carcinogenic (i.e., cancer-causing), mu tagenic (i.e., causing genetic mutation which can lead to cancer), or teratogeni c (i.e., causing birth defects) effects on
humans or other life forms.

Volume of Hazardous Waste Pharmaceuticals

According to EPA, pharmaceuticals are co mmonly used for diagnosing, treating, or preventing an extremely broad range of medical prob lems and for cosmetic and lifestyle purposes. HWPs are generated by a large number of facilities from
different sectors across the country. However, estimates of the volume of HWPs

4 The LD50 and LC50 value is a measure of acute toxicity, and indicates the ability of a toxic or poisonous substance to kill half the population in animal studies after a specified test duration.

12-P-0508 3may be understated because of EPA’s fa ilure to identify any new HWPs since 1980. In addition, volumes may be understated because EPA believes that many health care facilities, such as hospita ls, are unaware of their RCRA reporting obligations 5 for hazardous waste. Further, fede ral regulations require only large quantity generators to repor t their hazardous waste gene ration types and volumes to EPA. EPA estimates that hospitals and reverse distributo rs generate about 15,000 tons of HWPs each year. We note that, by itself, volume is not the only meaningful measure of the potential HWP problem, as many pharmaceuticals are toxic at very low concentrations.

EPA’s Best Management Practices Guidance for Pharmaceuticals

EPA has taken some action to address c oncerns about possible effects on human
health and the environment from th e release of pharmaceuticals into the environment. In August 2010, EPA’s Offi ce of Water issued a draft guidance document, Best Management Practices for Unused Pharmaceuticals at Health
Care Facilities . As defined in this guidan ce, EPA’s goal is to keep pharmaceuticals out of U.S. waters. The guidance recommends best management practices (BMPs) to be used by health care facilities (e.g., hosp itals) to minimize the release of pharmaceuticals to the envi ronment. EPA identified these BMPs
after:

 site visits at 12 health care facilities;

 consulting with over 700 stakehol ders, including health care professionals, government entities, h ealth care industry associations, and companies that manage unused pharmaceuticals;

 review of disposal data from 20 hos pitals and long-term care facilities (e.g., nursing homes, assisted living facilities); and

 review of literature data, re ports, and state recommendations.

The guidance describes BMPs that EPA r ecommends to health care facilities, long-term care facilities, medical clinic s, and doctors’ offices, when managing and disposing of unused pharmaceuticals.

EPA’s 2008 Universal Waste Rule Amendment to Address Hazardous Waste Pharmaceuticals

In December 2008, EPA proposed to add HWPs to the UWR 6 . The UWR, originally issued on May 11, 1995, modifi ed RCRA hazardous waste regulations by establishing a set of streamlined requi rements for the collection of certain widely dispersed hazardous wastes, calle d ‘‘universal wastes.’’ According to

5 Hazardous waste generators producing more than 2,200 pounds of hazardous waste, or more than 2.2 pounds of acute hazardous waste, in a calendar month must report the waste type and volume to EPA every 2 years. The total volume of hazardous waste reported in 2009 was approximately 35 million tons.

6 Federal Register: December 2, 2008 (Vol ume 73, Number 232), Page 73519-73544, at http://www.epa.gov/fedrgs tr/EPA-WASTE/2008/Decem ber/Day-02/f28161.htm

.

12-P-0508 4EPA, the proposed 2008 rule would facili tate better and environmentally sound management of pharmaceutical wastes by st reamlining the generator requirements and encouraging generators of HWPs to manage them under the provisions of the
UWR. EPA believed this would ensure that HWPs are properly disposed of and treated as hazardous wastes. In 2009, EPA summarized comments on the proposed rule. According to EPA, there was substantial negative comment on the proposed rule such that the Agency d ecided that it coul d not address the comments without re-proposing a new rule . EPA has recently stated that the Agency has decided to develop another proposal for health care facility-specific regulations for the management of hazardous waste pharmaceuticals.

Other Federal Agency Hazardous Drug Lists

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for c onducting research and maki ng recommendations for the prevention of work-related injury and illness. NIOSH publishes a List of Antineoplastic (e.g., chemotherapy) and Ot her Hazardous Drugs in Health Care Settings, also referred to as the NIOSH Dr ug Alert list, listing what it believes
should be handled as hazardous material s. The Occupational Safety and Health Administration (OSHA) hazard communicati on standard requires facilities to identify hazardous drugs that must be handled using special precautions. OSHA developed a hazardous drug list in the early 1990s and it remains a primary reference for identifying dr ugs that should be handled as hazardous waste. OSHA lists 61 pharmaceuticals on its hazardous drug list and the latest version of the NIOSH list published in 2010 includes 157 drugs.



### Scope and Methodology

We conducted our work from August 2011 to February 2012 in accordance with generally accepted government auditing stan dards. Those standards require that we plan and perform the evaluation to obt ain sufficient, appropriate evidence to provide a reasonable basis for our fi ndings and conclusions based on our objectives. We assessed whether EPA has a systematic process to identify and appropriately classify pharmaceuticals as h azardous waste and to ensure their safe disposal. We believe the evidence obtain ed provides a reasonable basis for our findings and conclusions based upon our objectives.

We interviewed program and informati on technology staff of the EPA Office of Resource Conservation and Recovery (ORCR), scientists and program staff of the EPA Office of Research and Developm ent, and staff of the EPA Region 9 Waste Management Division Enforcement. We interviewed state environmental protection program staff from Minne sota, Washington, and California. In addition, we interviewed staff from the U.S. Drug Enforcement Agency’s Office of Diversion Control in Washington, DC; and the Director of PharmEcology, a Waste Management company.

12-P-0508 5We reviewed EPA and state programs, regulations, and guidance documents related to HWPs, including EPA’s Propos ed UWR and BMP guidance. We also reviewed the following documents to identi fy potential HWPs and toxicity data:

 EPA P- and U-lists of hazardous waste.

 EPA Endocrine Disruptors list.

 NIOSH Drug Alert list of hazardous pharmaceuticals.

 OSHA Chemical list and Carcinogen list.



### Prior Evaluation Coverage

The following Office of Inspector General (OIG) and GAO reports addressed
issues related to the scope of our review:

 OIG Report No. 11-P-0215, EPA’s Endocrine Disruptor Screening Program Should Establish Management C ontrols to Ensure More Timely
Results , May 3, 2011.

 GAO Report No. GAO-11-346, Environmental Health: Action Needed to Sustain Agencies’ Collaboration on Pharmaceuticals in Drinking Water

, August 8, 2011

.

12-P-0508 6

# Chapter 2 EPA Has Not Used Its Authority to Assess and Manage Potential Hazards of Pharmaceutical Waste

Although EPA has the authority under RCRA, it has not added to its regulations pharmaceuticals that may qualify as hazar dous waste since 1980. EPA also has not established a process for the re gular identificati on and review of pharmaceuticals that may qualify for regul ation. EPA believes many health care facilities flush HWPs down drains, a pot entially harmful disposal method. In 2008, EPA proposed an amendment to the UW R, in part to address health care facilities’ unfamiliarity or confusion w ith RCRA requirements. However, the rule has been stalled since 2009 and EPA ju st recently decided it would develop another proposal for healthcare facility-s pecific regulations for the management of HWPs. Given the proliferation of pharmaceutical development since RCRA was enacted, EPA inaction on adding to its regulations pharmaceuticals that qualify as hazardous waste may result in unsafe disposal and releases of dangerous pharmaceuticals into the environment.



### EPA Has Not Used Its Hazardous Waste Management Authority

In 1980, EPA identified approximately 31 ch emicals used as pharmaceuticals that
met the RCRA hazardous waste criteria but EPA has not updated its list since that time. Moreover, EPA has not established a process for the regular identification and review of pharmaceuticals that ma y qualify for regulation as HWPs. The Food and Drug Administration has approved an average of 30 new drugs each year since 1996. Consequently, RCRA hazardous waste regulations are not keeping up with drug development and th e potential hazards they may pose if mismanaged and disposed without the neces sary protections to human health and
the environment. Without an establishe d process to review pharmaceuticals, EPA cannot ensure that it has identified phar maceutical contaminants that may pose a
hazardous risk to human health and the environment.

Many More Drugs Than EPA Has Identified May Be Hazardous

There are more than 100 drugs that NIOSH and OSHA have identified as hazardous but may not have been reviewed by EPA to determine if they qualify for hazardous waste regulation. We reviewed both lists and identified eight chemicals from the NIOSH list of hazardous pharmaceuticals that meet EPA criteria for regulation as acute hazar dous waste, but are not regulated. 7 We also identified three U-list pharmaceuticals th at meet P-list criteria based on rat oral
LD50 values. 7 Further, we identified at least 21 additional pharmaceuticals with

7 See appendix A for additional details.

12-P-0508 7LD50 values between 50 and 500 mg/kg, wh ich are within the range of values found for existing U-list pharmaceuticals. 8

According to EPA’s 2010 draft guidance, Best Management Practices for Unused
Pharmaceuticals at Health Care Facilities , many health care facilities, such as hospitals, use the NIOSH list of haza rdous materials to identify unused pharmaceuticals that should be handled si milarly to hazardous waste as defined under RCRA. The draft guidance further states that, alt hough RCRA does not require facilities to manage NIOSH-liste d hazardous materials the same as RCRA hazardous waste, EPA recommends RCRA guidelines as a BMP for managing NIOSH-listed hazardous materials. Drugs considered hazardous by the NIOSH
definition include those that exhibit charac teristics in humans or animals, such as carcinogenicity (cancer-causi ng), reproductive toxicity, organ toxicity at low doses; and structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria. There are 157 drugs identified on the NIOSH Drug Alert list that NIOSH recommends handling as hazardous materials to avoid occupational exposure. Thes e include chemotherapy drugs, hormones (e.g., estrogens), and antibiotics.

In comments to EPA on EPA’s August 2010 guidance document, Best Management Practices for Unused Pharma ceuticals at Health Care Facilities , the
state of Minnesota noted that because EPA has not reviewed any pharmaceuticals for regulation as hazardous waste sin ce the promulgation of RCRA regulations (i.e., 1980), some dangerous pharmaceutical s are not subject to more rigorous regulation as hazardous or acute hazardous waste. Specifically, the state said:

The proliferation of pharmaceutical development since the promulgation of RCRA regulations , coupled with the absence of any updates to the U- or P-lists, results in some extremely dangerous pharmaceutical waste (e.g ., chemotherapeutic drugs) not being listed or characteristic on ce fully evaluated, while other pharmaceutical waste (e.g., warfarin and nicotine) that is much less hazardous in finished drug form is regulated as acutely toxic waste.
The fact that there is still no fe deral mandatory waste management regulation for most chemotherapy drugs is alarming. Encouraging
health care facilities to ma nage NIOSH hazardous drugs as hazardous waste does not adequately address the danger.

In addition, in its comments on EPA’ s 2008 UWR amendment, the state of Minnesota also reflects the problem with not having a regular process to evaluate pharmaceuticals for hazardous waste regula tion. Specifically, the state said:

The P-List of hazardous waste is out- of-date to the extent that it is largely irrelevant with regard to currently used pharmaceuticals

8 This potentially defines possible candidate U-list phar maceuticals. U-listing requires additional justification beyond an LD50 value.

12-P-0508 8and hence currently generated pharmaceutical waste. Many of the hazardous pharmaceuticals that are listed on either the P-List or U-List are no longer in common us e. At the same time, a plethora of new, more toxic pharmaceuticals are not listed at all, despite the fact that they are being generated in a wide variety of health care
facilities.



### Health Care Facilities May be Un aware of Their RCRA Obligations

EPA has learned, from its communication with stakeholders, and stated in its costbenefit analysis of the 2008 Universal Wa ste proposed rule, that “many healthcare facilities have been unable to comply w ith the RCRA hazardous waste regulations as they relate to hazardous pharmaceutical wastes and often manage these wastes improperly.” 9 According to EPA, health care workers, retail pharmacy employees, and other pharmaceutical generators ar e often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to improperly dispose of hazardous pharmaceuticals as municipal or bulk wastes.
Outreach and enforcement efforts undertak en in Minnesota and Washington have
indicated that confusion and a lack of awareness exist among health care facilities, such as hospitals, regarding th e applicability of RCRA regulations to their pharmaceutical wastes. EPA also ac knowledges that many health carerelated facilities are unaware of their RCRA obligations, or, even if there is knowledge of RCRA, they have problems training workers to properly manage
hazardous wastes. ORCR staff informed us that they could implement outreach
activities to assist with education and compliance. However, at this time, EPA does not have a comprehensive outreach and compliance assistance plan for HWPs that states can use to improve RCRA compliance.

Improper Management of Pharmaceuti cals in Health Care Facilities

State environmental agencies in Mi nnesota and Washington have conducted
outreach and enforcement activities in response to confusion and unfamiliarity among the health care industry about RCR A rules for HWPs. For example, the Minnesota Pollution Control Agency devel oped a Health Care Initiative in 2002 to address widespread noncompliance w ith RCRA regulations. They began with an outreach program that provided traini ng to the health care industry, followed by inspections and enforcement. From 2004 to 2007, they identified 2 million pounds of pharmaceuticals that had been properly managed as a result of compliance and enforcement activities. The Washington Department of Ecology created enforcement guidance and conduc ted outreach activ ities to educate hospitals about proper disposal of pharmaceutical wastes. These outreach efforts were in response to hospitals’ requests fo r clarification on how to identify and manage HWPs, particularly controlled substances.

9 Assessment of the Potential Costs, Benefits, and Other Impacts of Adding Pharmaceuti cals to the Universal Waste Rule, as Proposed. EPA-HQ-RCRA-2007- 0932-0010, October 2008, page 1.

12-P-0508 9In addition, EPA Regions 1 and 2 have incr eased enforcement activities related to improper disposal of hazardous pharmaceuticals. In 2004, Region 1 notified 250 hospitals in New England of its intent ion to enforce hazardous waste laws for health care facilities. In 2003 and 2004, Regi on 2 identified violations at health care facilities, leading to fines ranging from $40,000 to $280,000. In 2010, five hospitals and nursing homes were cited by the New York Attorney General for failure to properly identify, track, and dispose of pharmaceuticals and other
wastes defined as hazardous waste under RCRA.



### EPA Is Developing a New Pharmaceutical Rulemaking

In 2008, EPA proposed an amendment to it s 1995 UWR to provi de a system for disposing HWPs that is protective of public health and the environment. The proposed rule was aimed at streamlining the current regulati ons governing HWPs to ensure that larger quantities of th ese wastes are managed properly. By March 2009, EPA staff stated they had received approximately 100 stakeholder
comments on the rule. Stakeholders commenting on the proposal expressed
concerns over the lack of notification and tracking require ments for facilities that handle and transport universal pharmaceutical wastes. According to EPA, generators of HWPs also have expres sed concerns related to making hazardous waste determinations, changes in genera tor status resulting from generation of acutely hazardous waste, regulation of additional pharmaceuticals as RCRA hazardous waste, and accumulation time limits.

Shortly after receiving a nd reviewing public comments in 2009, EPA determined that the 2008 UW proposal could not be used as a basis for a final rule that would
address commenters’ concerns. In the re sponse to the draft report (see Appendix B) ORCR staff said that in the fall of 2010, they began developing a new proposal for the health care industry for managing hazardous waste pharmaceuticals. ORCR staff further stated that in Sept ember of 2011 the Agency completed Early Guidance, the first of three major milestones in its rule development process, and completed Option Selection, the sec ond milestone, in April of 2012. They acknowledged that there are issues not properly addressed within the current version of the proposed rule and are work ing to identify areas that need to be
addressed in the future version of the ru le. Until a rule is finalized, concerns raised by pharmaceutical waste genera tors related to identification and management of hazardous pharmaceuticals, generator status, and accumulation
time limits remain unresolved. EPA has rece ntly stated on its UWR website that “the Agency has decided to develop a nother proposal for health care facilityspecific regulations for the management of hazardous pharmaceutical wastes in order to provide a regulatory scheme th at addresses the unique issues that hospitals, pharmacies and other health care -related facilities face. It is anticipated that the proposal will be available for public comment in Spring 2013.” EPA has also included updated information on the UWR status in the EPA Fall 2011 Regulatory Agenda.

12-P-0508 10

### Conclusion

For more than 30 years, EPA has not used its RCRA authority to determine whether pharmaceuticals may qualify as haza rdous waste. This may mean some drugs are disposed and managed in ways that are not safe for humans and the
environment. EPA’s belief that there is widespread noncompliance in the health care industry with RCRA hazardous wast e regulations further compounds the potential risks to human h ealth and the environment from unregulated HWPs. In addition, the idle status of EPA’s rule to improve management of HWPs, coupled with its primary reliance on “best manageme nt practices” to ensure human health and environmental protection, represent small steps in an environment where hundreds of pharmaceutical products are widely used throughout the nation. EPA has recently published its intent to de velop another proposal to address the management of pharmaceutical wastes at health care facilitie s. Over 100 drugs have been identified by other federal agencies as hazardous pharmaceuticals,
whereas EPA has identified 31 hazar dous pharmaceutical compounds. If EPA’s hazardous waste rules do not keep up with new drug development or ensure that regulated entities understand and comply with their obligations, uncertainties
about human health and environmental risks from hazardous pharmaceuticals are likely to grow.



### Recommendations

We recommend the Assistant Administrator for Solid Waste and Emergency Response:

1. Identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

2. Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous

waste.

3. Develop a nationally consistent outreach and compliance assistance plan to help states address challenges that health care facilities, and others as n eeded, have in complying with RCRA regulations for managing HWPs.



### Agency Response and OIG Evaluation

We reviewed the Office of Solid Wast e and Emergency Response’s (OSWER’s) comments and made changes to the repor t as appropriate. Appendix B provides the full text of OSWER’s response and the OIG’s comments.

12-P-0508 11OSWER does not clearly agree or disa gree with recommendations 1 and 2, and agrees with recommendation 3. In it s response to recommendation 1, OSWER agrees that pharmaceuticals are a category of chemicals that need attention and stated that it has recently completed a rese arch effort to identify and evaluate new and existing pharmaceuticals for potential addition to the lists of regulated hazardous wastes. In its response to reco mmendation 2, OSWER states that it will consider the next steps it can take when it completes actions on recommendation 1. OSWER acknowledges that the next steps co uld include activities consistent with
OIG recommendation 2. We will continue to recommend that EPA adopt a process to review new pharmaceuticals to determin e whether they qualify for regulation as hazardous waste, because listing of hazar dous waste is integral to the RCRA

program.

All recommendations are listed as unreso lved. In its 90-day response to this report, EPA should indicate agreement or disagreement with recommendations 1
and 2 and include a detailed corrective act ion plan with estimated milestone dates
for all recommendations.

12-P-0508 12

## Status of Recommendations and Potential Monetary Benefits

POTENTIAL MONETARY RECOMMENDATIONS BENEFITS (in $000s)

Rec. No. Page No. Subject Status 1 Action Official Planned Completion
Date Claimed
Amount Agreed-To
Amount

1

2

3 11

11

11 Identify and review existing pharmaceuticals to determine whether they qua lify for regulation as hazardous waste.

Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

Develop a nationally consistent outreach and compliance assistance pl an to help states address challenges that health care facilities, and others as needed, have in complying with RCRA regulations for managing HWPs. U

U

U Assistant Administrator for Solid Waste and Emergency Response

Assistant Administrator

for Solid Waste and Emergency Response

Assistant Administrator

for Solid Waste and Emergency Response

O = recommendation is open with agreed-to corrective actions pending C = recommendation is closed with all agreed-to actions completed U = recommendation is unresolved with resolution efforts in progress

12-P-0508 13 1Appendix A


## Pharmaceuticals Meeting Acute Hazardous Waste Criteria

Pharmaceutical P/U code Rat Oral LD50 (mg/kg)

NIOSH-listed hazardous pharmaceuticals not listed as EPA hazardous waste

Carmustine None 20

Cisplatin None 25.8

Colchicine None 26 Dactinomycin None 7.2

Mechlorethamine None 10 Oxytocin None 20.52 Thiotepa None 23

Vinorelbine tartrate None 26

P-listed RCRA hazardous waste pharmaceuticals

Arsenic trioxide P012 14.6

Epinephrine P042 30

Nicotine P075 50 Nitroglycerin P081 105

Phentermine P046 Rat oral LD50 not found Physostigmine P204 4.5 Physostigmine salicylate P188 Rat oral LD50 Not found

Warfarin >0.3% P001 1.6 U-listed RCRA hazardous waste pharmaceuticals with P-level LD50 values Melphalan U150 11.2 Mitomycin C U010 30

Uracil mustard U237 3.55

Source: OIG analysis. Rat oral LD50 values were obtaine d from toxicity data at the National Library of Medicine ChemIDPlus Advanced website. The value for Vinorelbine tartrate was obtained from an Internet Material Safety Data Sheet, and Colchicine was obtained from a Food and Drug Administration abstract. The NIOSH chemicals listed are those we could identify that meet EPA’s criteria for regulation as acute hazardous waste but are not regulated.

12-P-0508 14Appendix B


## Agency Response to Draft Report and OIG Comment

MEMORANDUM

SUBJECT: Response to the Office of Inspect or General Draft Audit Report, EPA Inaction in Identifying Hazardous Pharmaceutical Waste May Result in Unsafe Disposal

FROM: Mathy Stanislaus
Assistant Administrator

TO: Elizabeth Grossman Acting Assistant Inspector Gene ral for Program Evaluation Office of Inspector General

Thank you for the opportunity to review and respond to the Office of Inspector General (OIG) draft audit report, EPA Inaction in Identifying Hazard ous Pharmaceutical Waste May Result in Unsafe Disposal . The purpose of this memorandum is to transmit the Office of Solid Waste and Emergency Response’s (OSWER) re sponse to the OIG draft report and its
recommendations. This memorandum addresses th e report’s recommendations; Attachment 1 provides detailed comments on the report.

Before responding to the recommendations, however, I would like to provide some background on the Resource Conservation and Recovery Act (RCRA) hazardous waste identification regulations. This serves as c ontext for the issue that you have raised on pharmaceuticals. The basic RCRA waste identificati on regulations were firs t established in 1980. Major revisions were made in response to th e Hazardous and Solid Waste Amendments (HSWA) of 1984. We added additional listings of hazardo us wastes required unde r HSWA for wastes from specific sources; the final listing was comp leted in 2005. In 1990 we revised the Toxicity Characteristic, also in response to a HSWA direct ive. Since that time, new technologies, such as nanotechnology and biotechnology, and new and modi fied organic and inor ganic chemicals are constantly being developed, generating new wast es that may pose risks when disposed of.
Resources to evaluate new waste streams and regulate them appropriately are increasingly limited. Within these limitations, however, we are working to address those that most need
attention.

12-P-0508 15OIG RECOMMENDATIONS AND OSWER RESPONSES

OIG Recommendation 1 : Identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

OSWER Response 1 :

OSWER agrees that pharmaceuticals are a catego ry of chemicals that need attention and has recently completed a research effort to identify and evaluate new and existing pharmaceuticals for potential addition to th e lists of regulated hazardous wastes.

To make the best use of our very limited re sources, we have prioritized our work in a number of ways. First, we focused on pharmaceutical s that had been identified as chemicals of concern in processes designed to identify pha rmaceuticals of high risk already conducted by other federal agencies. We used lists developed by the National In stitute for Occupational Safety and Health (NIOSH) and the Occupational Sa fety and Health Ad ministration ( OSHA). 10 Second, we gathered readily available existing toxicological information about these pharmaceuticals. Third, we compared the existing available information to the defined regulatory standard for identifying acutely hazardous waste. The work that we conducted and the results we found were similar to the research recently done by your staff as part of your investigation and presented in the Appendix to your report.

OSWER is now reviewing the results of this project and deciding on next steps that could be completed within available resources to addre ss identified potential ri sks from disposal of pharmaceuticals. (See Attachment for further disc ussion regarding the listing of hazardous waste pharmaceuticals.) Possible next steps range fr om taking no action to potential regulatory considerations. We caution that, due to limited resources, the work we have conducted is narrow in scope and has a number of limitations. As we ev aluate next steps, we will consider whether
and how these limitations could be a ddressed with available resources.

OIG Response: OSWER does not clearly agree or di sagree with this recommendation. However, OSWER agrees that pharmaceuticals are a cate gory of chemicals that need attention and stated that it has recently completed a re search effort to identify and evaluate new and existing pharmaceuticals for potential addition to th e lists of regulated hazardous wastes. In its 90-day response to the final re port, OSWER should agree or di sagree with the recommendation, and, as appropriate, provide actu al or estimated milestone co mpletion dates for actions to respond to this recommendation. In addition OSWER should provide a complete description of its corrective action plan for this recommendation. This recommendation will be designated as unresolved in the final report.

OIG Recommendation 2 : Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

10 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 (157 drugs) and OSHA Technical Manual, Section VI, Chapte r 2, Appendix VI:2-1 Some Comm on Drugs Considered Hazardous (61 drugs).

12-P-0508 16OSWER Response 2 :

As part of OSWER’s decision on next steps as discussed in Response 1, we will consider the appropriate next steps to ta ke given significant resource constr aints and competing priorities. The next steps to be considered could in clude a process to re view newly developed pharmaceuticals.

OIG Response: OSWER’s response to recommendation 2 is linked to its response on recommendation 1, which OSWER does not clearly agree or disagree with. OSWER states that it will consider the next steps it can take when it completes actions on recommendation 1. OSWER acknowledges that the next steps could include activities consistent w ith OIG recommendation 2. We continue to recommend that EPA adopt a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste, because listing of hazardous waste is integral to the RCRA program. As stated in EPA’s RCRA Orientation Manual , “Proper
hazardous waste identification is essential to the success of the RCRA program.” This recommendation will be designated as unresolved in the final report. In its 90-day response to the report, EPA should indicate agreement or di sagreement with recommendation 2, and, as appropriate, provide estimated milestone comple tion dates for agreed-to corrective actions along with a description of th e corrective action plan.

OIG Recommendation 3 : Develop a nationally consistent outreach and compliance assistance plan to help states address ch allenges health care facilities, an d others as needed, have in complying with RCRA regulations for managing HPWs. 11

OSWER Response 3 :

OSWER agrees with the recommendation. Our re sponse includes three planned phases: 1) continue ongoing outreach and compliance assist ance for the current regulations; 2) propose revisions to RCRA regulations to more effectively address hazardous waste pharmaceuticals in the health care sector; and 3) as we do for all new rules, develop a communications plan detailing outreach efforts to implement the new regulations.

 Phase 1: We note that OSWER and the Office of Enforcement and Compliance Assurance (OECA) have already done a great deal of work to assist states and the regulated community with implementation of and compliance with the current RCRA regulations for hazardous waste pharmaceutical s. Examples are listed below. Within available resources, we will continue these kinds of outreach and compliance assistance efforts for the current regulations.

1. Healthcare Environmental Resource Center (HERC) - HERC provides compliance assistance and pollution preven tion information to the healthcare sector. It is funded by OECA 's Office of Compliance, managed by the Office of Chemical Safety and Pollution Prev ention, and OSWER provides technical expertise on RCRA. HERC offers complian ce assistance to healthcare facilities

11 Hazardous pharmaceutical waste.

12-P-0508 17and veterinarians, and a cente r devoted to dentists is currently being developed. ( http://www.hercenter.org)

2. "Managing Pharmaceutical Waste: A 10-Step Blueprint for Hea lthcare Facilities in the United States" (The Blueprint) - The Blueprint provides hospitals a step-by

step guide for developing and implementing a comprehensive pharmaceutical waste management program. While the most recent version (revised August 2008) was funded by HERC, the original Blue print (April 2006) was funded by OSWER and managed by EPA Region 1. The Of fice of Resource Conservation and Recovery Staff (ORCR) staff reviewed and provided comments on both versions. ( http://practicegreenhealth.or g/sites/default/files/upload

files/ pharmwasteblueprint.pdf )

3. Development of healthcare-specific memoranda: Through guidance memoranda,
OSWER has addressed various healthcare- specific pharmaceutical waste issues that have been raised by the regulated community. For example, most recently, inNovember 2011,ORCR issued guidance for managing containers that held Plisted pharmaceuticals, most commonly wa rfarin and nicotine. The guidance outlined several approaches generators may be able to use to address this issue. In particular, the EPA pointed out that only th e weight of the resi due in the container counts towards the generator status and that the container itself is not a hazardous waste. This guidance has been ve ry well received by the industry.

4. Outreach: OSWER maintains close communi cation with stakeholders on these issues and has made numerous presen tations on pharmaceutical waste issues, including updates on the pharmaceutical ru lemaking, at conferences and webinars hosted by the regulated community and by EPA.

 Phase 2: As noted in your report, we are in the process of developing major revisions to the hazardous waste regulations to make them more effective for the health care sector and the hazardous waste pharmaceuticals they gene rate. This step will help states with implementation and the regulated comm unity with compliance with the RCRA regulations for hazardous waste pharmaceutical s. Our current plans anticipate publication of a proposed rule in March 2013.

 Phase 3: As we do for all new rules, as we complete the revisions to the regulations, OSWER will develop a co mmunications plan detailing outreac h steps to assist states with adoption and implementation of the new re gulations and to assist the regulated community with learning about and coming in to compliance with the new regulations.

OIG Response: OSWER agrees with recommendati on 3. OSWER is taking steps to
communicate with health care facilities to assist compliance with RCRA regulations for managing HWPs. The activities described meet the intent of the recommendation. However, because estimated or actual milestone dates were not included, this recommendation will be listed as unresolved in the final report. In it s 90-day response to the report, EPA should provide estimated or actual completion dates for the milestones.

12-P-0508 18OSWER welcomes the opportunity to conti nue working with OIG to implement these recommendations and to strengthen its hazardous waste identificati on program. If you have any questions, please contact Suzanne Rudzinski, in the Office of Resource Conservation and Recovery, at (703) 308-8895.

Attachment

12-P-0508 19ATTACHMENT EPA Comments on OIG February 29, 2012 Draft Report EPA Inaction in Identifying Hazardous Pharmaceutical Wast e May Result in Unsafe Disposal

GENERAL COMMENT REGARDING HAZ ARDOUS WASTE IDENTIFICATION

The report does not appear to fully appreciate the comp lexities of listing a chemical as a commercial chemical product. The report says (page 3):

P and U lists of chemicals – hazardous wastes incl uding specific unused c hemicals. Chemicals are included on the U list based on toxicity and characteristics. Chemicals are included on the P list if they are acutely toxic. P list chemicals ar e managed more stringently than U list chemicals.

The report correctly cites the criteria for listing chemicals as P-listed waste. However, the description for Ulisted chemicals is much too simplified and does not fu lly delineate the process for listing a chemical on the U-list. The report states (pages 3 and 7 - 8):

Pharmaceuticals can be included on the U list if they exhibit any of the hazardous characteristics described above, or if they c ontain a toxic constituent and are capable of posing a “substantial present or potential hazard to human health or the environment w hen improperly treated, stored, transported, or disposed of, or otherwise managed.”

Further, we identified at least 21 additional pharmaceuticals with LD50 values between 50 and 500 mg/kg, which are within the range of val ues found for existing U-list pharmaceuticals. 8

8 This potentially defines possi ble candidate U-list pharmaceutical s. U-listing requires additional justification beyond an LD50 value.

In fact, the process for listing chemicals on the U-list is not a matter of simply comparing LD50 values. Therefore, the results provided in the report using such a comparison are not meaningful. As the report itself noted (page 3), unless a pharmaceutical exhibits any of the hazardous characteristics, listing a chemical on the U-list requires that the Agency demonstrate t hat the chemical poses a “substantial present or potential hazard to human health or the environment” when improperly managed. The regulations for this listing approach are set out in 40 CF R 261.11(a)(3). These regulations specify a number of factors that must be considered, including:

 the toxicity and concentrations of the hazardous constituents in the waste,

 the quantity of the waste generated,

 the potential for the constituents to migrate, persist, and bioaccumulate in the environment,

 any cases of environmental dam age from improper management, and

 plausible types of m anagement of the waste.

For all recent listings, EPA has used risk assessment tools to assess potential risks from waste management to encompass most of these factors. Furthermore, whether a waste is listed or not depends to a great degree on how the waste is being managed. That is, the waste must present a “substantial” hazard

12-P-0508 20based on “plausible” management practices. Therefore, while the inherent to xicity of a chemical in a waste is important, the other factors in 261.11(a)(3) must be considered in eval uating a chemical for listing as a U-list hazardous waste. This type of assessment requires a large amount of information about a waste, and listing a waste using these criteria requi res a significant effort and resources.

OIG Response: The OIG acknowledges the potential co mplexity beyond LD50 values for U-listed waste. The report specifical ly states criteria for U-listing in EPA Definition of Hazardous Waste Chapter 1 pages 2-3, and also states in Chapter 2 footnote 8 page 8 that Ulisting requires additional justification.

SPECIFIC COMMENTS

Entire report:

1. When referring to wastes that are currently i dentified by RCRA regulation as hazardous waste, recommend using the term “Hazardous Waste P harmaceutical” (HWP) instead of “Hazardous Pharmaceutical Waste” (HPW). Because “hazardous waste” is a s pecific regulatory phrase, it is clearer to use it directly in the term. Also recommend using another term, such as “non-regulated pharmaceutical waste” for discarded pharmaceuticals that may be of concern, but are not currently regulated under RCRA. This would clarify whether the text is referring to RCRA-regulated or nonregulated pharmaceutical wastes.

OIG Response: The term “Hazardous Pharmaceutical Waste (HPW)” has been changed in the report to “Hazardous Waste Pharmaceutical (HWP)” as requested by OSWER. We note that this represents a recent change, as HPW was used in prior EPA publications such as the 2008 proposed universal waste rule and the 2010 draft Guidance Document: Best Management Practices for Unused Pharmaceutic als at Health Care Facilities . HWP was most recently used
in OSWER’s Management Standards for Hazardous Waste Pharmaceuticals published in the Fall 2011 Regulatory Agenda. However, we note that OSWER continues to use the term “hazardous pharmaceutical wastes” in recent updat es to its UWR website. We suggest that OSWER consistently use “hazardous waste pharmaceuticals” in all future publications. The report uses “unregulated HWP” to refer to pha rmaceutical wastes not currently regulated by RCRA, instead of “non-regulat ed pharmaceutical waste.”

2. Recommend using the term “active pharmaceutical ingredients (APIs)” when discussing chemicals

in the environment since environmental analysis tests for individual APIs.

OIG Response: This change will not be incorporated, as it would add unneeded complexity to the terminology of the report.

12-P-0508 21At a Glance:

3. Background, left-hand column, 2 nd

sentence: Add drinking water to the list of types of water where

APIs are found.

OIG Response: “Drinking water” added as suggested.

4. Background, left-hand column: When discussing APIs in wa ter it is important to note that: 1) While improper disposal of drugs contributes to the presence of APIs in our nation’s waters, other contributions include excretion and pass-through fr om POTWs; and 2) Ava ilable studies identify very few APIs in water that are regulated hazardous wastes.

OIG Response: This point will not be added to the B ackground in the At a Glance section. The
additional level of detail is not appropriate for this section, which is intended to provide a snapshot of what the report is about.

5. “What We Found,” 1 st paragraph, 5 th

sentence: For accuracy, revise to read “We identified eight chemicals found in pharmaceuticals that meet EPA’s criteria for regulat ion as acute hazardous waste but wastes containing these chemicals are not regulated, unless they exhibit a

characteristic.”

OIG Response: The important point in this statement is that these pharmaceuticals have not been specifically identified by EPA for regulation as acute hazardous waste even though they meet the toxicity criteria. “A s such” added to the end of th e sentence for clarification.

6. “What We Found,” 1 st paragraph, 6 th

sentence: For accuracy, revise to read “There are over 100 drugs that federal occupational safety organizations have identified as hazardous but have only recently been reviewed by EPA to determine whether they may qualify as hazardous waste. As a result of comments received on the proposed rule for pharmaceutical wastes, EPA started an

examination of the lists from OSHA and NIOSH fo r potential candidates for listing as commercial chemical products. EPA found that relatively few of them would meet the criteria for listing as acute

hazardous waste under the commercial chemical product listings (40 CFR 261.33(e)), similar results to those found by the OIG in its work for this study.”

OIG Response: No change was made because the refere nced sentence is accurate as written. A new sentence was added to acknowledge EPA’s st ated efforts: “EPA st aff stated they have started examining these drugs for listing as hazardous waste.”

7. “What We Found,” 2 nd

paragraph, 3 rd

sentence: Delete and replace with “This may result in mismanagement of hazardous waste pharmaceutical s.” Note: RCRA regulations generally allow drain disposal of HW. The domestic sewage excl usion of 40 CFR 261.4(a)(1 )(ii) is designed to avoid duplicative regulation under the Clean Water Act and RCRA and thus defers coverage of domestic sewage to the Clean Water Act regulations.

12-P-0508 22OIG Response: Sentence changed as suggested.

8. “What We Found,” 3 rd

paragraph: Delete 2 nd

sentence.

OIG Response: No change was made. The sentence stat es that no action has occurred on the 2008 UWR since 2009. EPA states in the Fall 2011 Regulatory Agenda, “...EPA is considering re-proposing healthcare facil ity-specific regulations for the management of hazardous pharmaceutical wastes...,” but no specif ic action has yet been taken.

9. “What We Found,” 3 rd

paragraph, 3 rd

sentence: For accuracy, revise to read “EPA staff informed us that, due to substantial negative public comments received on the 2008 universal waste proposal, the Agency is developing a revised proposal for regulation of hazardous wa ste pharmaceuticals at

healthcare facilities.”

OIG Response: Sentence modified to incorporate this comment.

Table of Contents:

10. Suggest including the word “findings” in the title of Chapter 2 for clarity.

OIG Response: No change was made. This is an editori al comment and it is our opinion that the title is an appropriate description of the cont ents of the chapter.

Chapter 1:

11. Page 1, Background, 2 nd

sentence: Add a clarifying footnote at the end of the sentence to read “Note: very few, if any antibio tics and endocrine disrupters are HWP. In addition, they do not meet

the current hazardous waste listi ng/characteristic criteria.”

OIG Response: No change was made. This statement in the report is an accurate summary of statements in the GAO report, Environmental Health: Action Needed to Sustain Agencies’ Collaboration on Pharmaceuticals in Drinking Water , August 2011

. Further, EPA provides no evidence for the statement that “few, if any antibiotics and endocrine disrupters are HWP.”

12. Page 1, Background, 3 rd

and 4 th

sentences: Recommend providing references to sources for information presented about detrim ental effects of pharmaceutic als on aquatic species, etc.

OIG Response: These statements are based on information in the EPA Health Services Industry Study Management and Disposal of Unused Pharmaceuticals (Interim Technical Report) August 2008; and the GAO report, Action Needed to Sustain Agencies’ Collaboration on Pharmaceuticals in Drinking Water, August 2011.

13. Page 1, Background, 2 nd

paragraph, 1 st sentence: Replace definition of pharmaceutical, or explain

the source of this definition. At this time, EPA does not have a fo rmal definition of pharmaceutical. EPA proposed a regulatory definiti on of pharmaceutical in the 2008 proposal, but since the rule

12-P-0508 23was not finalized, that definition is not in plac e. FDA may have a definition that would serve the

purpose.

OIG Response: This definition is from the 2008 propos al. “In the 2008 proposed universal waste rule,” added for clarity.

14. Page 1-2, Background, last sentence: For clarity, revise to read “A Pharmaceutical becomes a waste when a decision is made to dispose of it. This can include unused but expired drugs (e.g., personal medications) and waste materials contai ning excess drugs, such as syringes, IV bags, tubing, vials, etc.”

OIG Response: No change was made. Footnote 1 speci fies that EPA does not regulate pharmaceuticals until they are discarded as waste, whic h is when a decision is made to dispose of
them.

15. Page 1, Footnote 1: Revise to read “Under RCRA, EPA can not regulate pharmaceuticals until a decision is made to dispose of it.”

OIG Response: No change was made. Footnote 1 speci fies that EPA does not regulate pharmaceuticals until they are discarded as waste, whic h is when a decision is made to dispose of
them.

16. Page 2, Footnote 2: To incorporate informat ion provided by public commenters on the 2008 proposed rule, revise to read “Rever se distributors are private compani es that provide a service to the health care industry by determining credit eligibility on returned pharmaceuticals and by facilitating the receipt of proper credit.”

OIG Response: The definition of distributors was ta ken directly from the 2010 EPA draft Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care
Facilities

.

17. Page 2, Background, Last sentence: For accuracy, revise to read “The domestic sewage exclusion at 40 CFR 261.4(a)(1)(ii) generally allows facilitie s to flush pharmaceuticals down the drain. However, due to the detection of active pharmaceutical ingredients in the environment, EPA recommends that facilities not dispose of their pharmaceuticals down the drain.”

OIG Response: The sentence is accurate as written, and was used by EPA in its 2010 draft Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care
Facilities . At the beginning of the sentence, we added the words “Although the domestic sewage exclusion generally allows facilities to flush pharmaceuticals down the drain,” to address this

comment.

18. Page 2, EPA Definition of Hazardous Waste, 3 rd

and 4 th

sentences: For accuracy, revise to read “Federally, any facility, such as a hospital or other health facility, that generates more than 100 kg

12-P-0508 24(220 lbs.) and less than 1000 kg (2200 lbs) of hazar dous waste per month, is a small quantity generator (SQG) under RCRA. A facility that generates greater than 1 kg (2.2 lbs.) of acute hazardous waste per month and/or 1000 kg (2200 lbs.) or more of ha zardous waste per month is a large quantity generator (LQG) under RCRA. Facilities that generate less than SQGs and LQGs per month have minimal RCRA requirements. Both SQGs and L QGs are subject to full RCRA hazardous waste regulation. Full RCRA regulatio ns generally include management standards for waste accumulation and required transportation by a hazardous waste trans porter to a permitted hazardous waste treatment, storage and disposal facility. “ DOT regulations require certain container packaging for transport, and RCRA defers to DOT on this.

OIG Response: The sentences are accurate as written, and the suggested revisions provide a level of detail not necessary for this report and, in our opinion, will impede readability of the report.

19. Page 2, “corrosivity”: For accuracy, revise to read “wastes that ar e extremely acidic or alkaline (basic).”

OIG Response: OIG’s definition is accurate. It is identi cal with the defini tions in the EPA’s
RCRA Orientation Manual 2011

.

20. Page 3, c: For accuracy, revise to read “Chemic als are included on the U-list based on toxicity or

other characteristics. Chemicals are included on the P-list if they ar e acutely toxic. P-list chemicals are regulated when generated in lower qu antities than U-list chemicals.”

OIG Response: Sentences changed as suggested.

21. Page 3, 1st full sentence: For accuracy, revise to read “P-listed wastes are identified as acute

hazardous waste because the waste has been found to be fatal to humans or animals above
certain thresholds/doses.”

OIG Response: Sentence changed as suggested.

22. Page 3, Footnote 4: For accu racy, revise to read “The LD 50 and LC 50 value is a measure of acute toxicity and indicates the ability of a toxic or poisonous substance to k ill half the population in animal studies within the study’s timeframe.”

OIG Response: Footnote wording changed to “The LD50 and LC50 value is a measure of acute toxicity, and indicates the ability of a toxic or poisonous substance to kill half the population in animal studies after a sp ecified test duration.”

23. Page 3, EPA Definition of Hazardous Waste, last paragraph, first sentence: Fo r clarity, revise to

read “Pharmaceuticals can be inclu ded on the U-list if they exhibi t any of the four hazardous

characteristics...”

OIG Response: “Four” added to the se ntence as suggested.

12-P-0508 2524. Page 3, Volume of Hazardous Pharmaceutical Waste, 3 rd

and 4 th

sentences: For accuracy, revise to read “However, estimates of the volume of HWP may be understated because under federal regulations, only large quantit y generators are required to repor t their hazardous waste types and

volumes.”

OIG Response: A new sentence was added after the fourth sentence: “Further, federal regulations require only large quantity generators to report their hazar dous waste types and
volumes to EPA.”

25. Page 3, Footnote 5: For clarity, revise to r ead “Hazardous waste generators producing more than 2,200 pounds of hazardous waste, or more than 2.2 pounds of acute hazardous waste, in a calendar month must report the waste ty pe and volume to EPA every 2 years.”

OIG Response: Sentence changed as suggested.

26. Page 3-4, sentence beginning “EPA estimates...”: Recommend additional context such as how much total hazardous waste is generated per year.

OIG Response: We added to footnote 5: “The total volume of hazardous waste reported in 2009 was approximately 35 million tons.”

27. Page 4, EPA’s Best Management Practices Guidanc e for Pharmaceuticals, last sentence: For accuracy revise to read “The draft guidance descr ibes BMPs that EPA recommends to health care facilities, long-term care facilities, medica l clinics, and doctors’ offices, when managing and disposing of unused pharmaceuticals. Numerous comments were received on the draft BMPs.”

OIG Response: No change was made. The statement is accurate as written and adding the suggested additional text is not necessa ry for purposes of the OIG’s report.

28. Page 4, last 2 sentences: For accuracy, revise to read: “In 2009, EPA summarized comments on the proposed rule. There was substantial negative comment on the proposed rule such that the Agency decided that it could not address the comments without re-pr oposing a new rule. Since the fall of 2010, the Agency has been actively develop ing a new proposed rule that addresses the

comments received on the Univ ersal Waste proposal.”

OIG Response: We added the following new sentences to reflect EPA’s current position on the rulemaking: “According to EPA, there was subs tantial negative comment on the proposed rule such that the Agency decided that it could not address the comments without re-proposing a new rule. EPA has recently stated that the Agency has decided to devel op another proposal for healthcare facility-specific regulations for the management of hazardous waste pharmaceuticals.”

29. Page 5, Other Federal Agen cy Hazardous Drug Lists, 2 nd

to last sentence: For accuracy, revise to read: “OSHA developed a hazardous drug list in the early 1990s and it remains a primary

12-P-0508 26reference for health care facilities for identif ying drugs that may pose occupational risks to employees.”

OIG Response: No was made change. The statement is accurate as written.

Chapter 2:

30. Page 7, 1 st sentence: For accuracy, revise to r ead “Although EPA has the authority under RCRA, it has not added to its regulations phar maceuticals that may qualify as hazardous waste since 1980.”

OIG Response: Sentence changed as suggested.

31. Page 7, 5 th

sentence: For accuracy, revise to read “How ever, the rule was stalled during the last half of 2009 and in early 2010. In the fall of 2010, EPA decided it would need to revise the proposed UWR or create a new rule. “

OIG Response: To reflect EPA’s current position, we ch anged the sentence from “However, the rule has been stalled since 2009 and EPA just re cently decided it would determine the need to revise the proposed UWR or create a new rule,” to “However, th e rule has been stalled since 2009 and EPA just recently decided it would deve lop another proposal for healthcare facilityspecific regulations for the management of HWPs.”

32. Page 7, 6 th

sentence: For accuracy, revise to read “Given the proliferati on of pharmaceutical development since RCRA was enacted, EPA inacti on on adding to its regulations pharmaceuticals that qualify as hazardous waste may result in unsafe disposal and releases of dangerous pharmaceuticals into the environment.”

OIG Response: Sentence revised as suggested.

33. Page 7-8, end of 1 st incomplete paragraph: Revise to reflec t information in the General Comment

on Hazardous Waste Identification.

OIG Response: No change was made. Additional requirements for U-listing are noted in the
footnote.

34. Page 8, 1 st full paragraph, 2 nd

sentence: For accuracy, revised to read “Currently, EPA recommends RCRA guidelines as a BMP for managi ng NIOSH-listed hazardous materials that are not currently regulated as HWP.” For complet eness, OIG should provide a citation for this

statement.

OIG Response: The statement is accurate as wr itten. The source is EPA’s 2010 draft Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

. However, OIG has added text from the draft Guidance Document to clarify that RCRA does not require facilities to manage NIOSH-listed hazardous materials the same as RCRA hazardous

waste.

12-P-0508 2735. Page 9, 1 st full paragraph: Add a reference to t he “2008 Universal Waste proposed rule.”

OIG Response: Text added to the first sentence on page 9 to clarify that the reference is to the 2008 Universal Waste proposed rule.

36. Page 9, 1 st full paragraph, 2 nd

sentence: Explain, or del ete the term “bulk waste.”

OIG Response: The term is from the 2008 Universal Wa ste proposed rule: page 73530, Federal Register Vol. 73, No. 232, December 2, 2008.

37. Page 10, 1 st paragraph: It would be helpful to explain what regulatory requirement the New York Attorney General used to cite hospitals for di sposing of pharmaceutical wastes down sinks and toilets. NY may have more stringent regulations r egarding drain disposal of hazardous wastes than

the current federal RCR A program, which includes the dom estic sewage exclusion of 40 CFR 261.4(a)(1)(ii).

OIG Response: The statement is based on public information released by the New York Attorney General. The sentence has been modified to address only violations clearly identified as
federal RCRA violations.

38. Page 10, Title - EPA Pharmaceutical Waste Rulemaking Has Stalled: The title appears to be a
remnant from before the se ction was updated to include recent rule development activity. Also see next comment for further updates. For accuracy, revise to reflect progress the Agency has made developing a new proposed rule to read “EPA is Making Progress On a New Pharmaceutical Waste Rulemaking.”

OIG Response: Title changed to “EPA Is Developi ng a New Pharmaceutical Rulemaking”

39. Page 10: 3 rd

paragraph, 1 st – 2 nd

sentences: To update and for accu racy, revise to read “Shortly after receiving and reviewing public comm ents in 2009, EPA determined that the 2008 UW proposal could not be used as a basis for a final rule that would address commenters’ concerns. ORCR staff said that in the fall of 2010, they began developing a new proposal for the health care industry for managing hazardous waste pharmac euticals. In September of 2011 the Agency completed Early Guidance, the first of three major milestones in its rule development process, and expects to complete Option Selection, the second milestone, in April of 2012.”

OIG Response: Sentences added as suggested, changed to reflect Agency completion of Option
Selection.

40. Page 11, 2 nd

sentence: For accuracy, revise to r ead “EPA’s belief that there is widespread noncompliance in the health care industry with RCRA hazardous waste regulations suggests that there may be potential risks to human health and the environment from r egulated hazardous waste pharmaceuticals.”

12-P-0508 28OIG Response: No change was made. This is an edito rial comment that is not materially different than OIG’s original conclusions.

41. Page 11, 3 rd

– 5 th

sentences: For accuracy, revise to read “In addition, because EPA’s rule to improve management of HWP must be re-proposed, the current RCRA HW generator regulations continue apply to generators of HWPs. The RCRA HW generator regulations can be challenging for healthcare facilities, which may result in non-compliance over the short term. Also, over 100 drugs have been identified by other federal agenc ies as pharmaceuticals that pose potential hazards, whereas EPA only regulates 31 pharmaceut ical compounds as listed hazardous wastes and additional pharmaceutical compounds as charac teristic hazardous wastes. The Agency has recently conducted a review of other federal agencies’ lists to begin to address this issue.” Note: The Agency does not rely on best management prac tices or BMPs to regulate pharmaceuticals that are hazardous waste, the current RCRA r egulations are in effect for hazardous waste pharmaceuticals.

OIG Response: No change was made. These are OIG conclusions.

Appendix A:

42. Page 13, Table, For accuracy, revise to read “P-listed RCRA Ha zardous Waste pharmaceuticals.”

OIG Response: “Hazardous” added to the heading as suggested.

43. Page 13, Table: For accuracy, for phentermi ne and physostigmine salicylate, add a footnote indicating the toxicity exposure route and LD dose t hat was the basis for the P-listing. Without the footnote, the chart seems to indicate that because no rat oral LD50 was found, there was no reason to list the chemical. However, both chemic als were listed based on toxicology information for one of three exposure routes.

OIG Response: No change was made. The statement about the lack of a rat oral LD50 does not imply that there was no reason to list the chemical based on EPA’s analysis. It simply states that
no rat oral LD50 was found.

44. Page 13, Table: For accuracy, revise column header to read: “U-list ed RCRA Hazardous Waste pharmaceuticals with P-level LD50 values.”

OIG Response: “Hazardous” added to heading consistent with the suggested change.

12-P-0508 29Appendix C



## Distribution

Office of the Administrator
Assistant Administrator for Solid Waste and Emergency Response Deputy Assistant Administrator for Solid Waste and Emergency Response Agency Follow-Up Official (the CFO) Agency Follow-Up Coordinator
General Counsel Associate Administrator for Congressi onal and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education Director, Office of Resource Conservation a nd Recovery, Office of Solid Waste and Emergency Response Audit Follow-Up Coordinator, Office of Solid Waste and Emergency Response

12-P-0508 30